Antidote For THC? Anebulo Releases Positive Clinical Data Showing Potential Of Its Drug For Treatment Of Acute Cannabinoid Intoxication

Anebulo Pharmaceuticals, Inc. ANEB announced complete results from its randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating ANEB-001 as a potential treatment for acute cannabinoid intoxication (ACI) in healthy volunteers challenged with oral THC. Part B of the study was an adaptive design that included six cohorts of up to 15 healthy adults to examine different doses of THC and ANEB-001, and the impact of delayed dosing of ANEB-001 or placebo. In total, Parts A and B of the phase 2 study enrolled 134 healthy subjects.

"The positive results of the Phase 2 proof of concept study are very encouraging and will have significant clinical implications for the unmet need of patients presenting to emergency departments with ACI," stated Simon Allen, CEO of Anebulo. "We believe the complete data from this study, together with data from our observational study in ACI subjects and our PK/PD modeling efforts, will provide support for the design of a registrational trial. We are in the process of requesting an end of phase 2A meeting with FDA to discuss the final data from this study. We expect the meeting to occur within 75 days from the date of the request but acknowledge that it could be longer."

Final ANEB-001 Part 2 Proof of Concept Study Results

Based on the final data for part B of the study, a single low oral dose of ANEB-001 (10 mg) administered 1 hour after a THC challenge rapidly and statistically significantly reversed key psychotropic effects of THC doses as high as 30 mg, including a reduction in the visual analog scale (VAS) for feeling high and improvement in VAS alertness and reduced body sway. In a pre-specified pooled analysis of data for the combined 21 mg or 30 mg THC dose levels, a single 10 mg of ANEB-001 administered one hour after THC achieved statistical significance on all primary outcomes, including a reduction in VAS feeling high, improvement in VAS alertness, reduced body sway, and reduction in heart rate. ANEB-001 also reduced the time required for the THC effects to normalize back to baseline.

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